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510(k) K163357

OneTouch Via On-Demand Insulin Delivery System by Lifescan Europe, A Division Of Cilag GmbH — Product Code OPP

K163357 is an FDA 510(k) premarket notification submitted by Lifescan Europe, A Division Of Cilag GmbH for the device "OneTouch Via On-Demand Insulin Delivery System". The FDA issued a decision of Substantially Equivalent on Jun 7, 2017. The device falls under product code OPP (Pump, Infusion, Insulin Bolus), a Class II device regulated under 21 CFR 880.5725.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 7, 2017
Date Received
Nov 30, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Insulin Bolus
Device Class
Class II
Regulation Number
880.5725
Review Panel
CH
Submission Type

The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.

Other clearances for product code OPP

  • K252757 — CeQur Simplicity™ On-Demand Insulin Delivery System (Apr 10, 2026)
  • K243273 — CeQur Simplicity™ On-Demand Insulin Delivery System (Nov 13, 2024)
  • K233447 — CeQur Simplicity™ On-Demand Insulin Delivery System (Jan 18, 2024)
  • K111924 — FINESSE PERSONAL INSULIN DELIVERY PATCH (Apr 10, 2012)
  • K100947 — FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 (Jun 28, 2010)
  • K093065 — FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000 (Jan 20, 2010)

FDA data resources